Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445686
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-29
Brief Title:
Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation
Sponsor:
Biosency
Organization:
Biosency
Study Overview
Official Title:
Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation REACT
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACT
Brief Summary:
The aim of this study is to assess the feasibility of early detection of acute exacerbations of idiopathic pulmonary fibrosis by the remote monitoring of vital signs
The main question the study aims to answer is Could a remote monitoring device allow for earlier detection of exacerbations with individualized monitoring and continuous data collection All patients will receive conventional clinical follow-up based on their health status and clinical recommendations At the same time they will benefit from the Bora Care medical remote monitoring device
The main question the study aims to answer is Could a remote monitoring device allow for earlier detection of exacerbations with individualized monitoring and continuous data collection All patients will receive conventional clinical follow-up based on their health status and clinical recommendations At the same time they will benefit from the Bora Care medical remote monitoring device
Detailed Description:
All patients will receive conventional clinical follow-up based on their health status and clinical recommendations At the same time they will benefit from the Bora Care medical remote monitoring device
To do this they will be equipped with a Bora Band connected wristband that measures vital signs at home and the Bora Box Gateway that ensures connectivity and allows automatic data uploading in real time to the Bora Connect data visualization platform
The home healthcare provider Air de Bretagne will be involved in the study to support each patient in the use of the connected wristband
At the end of the follow-up period the collected data will be retrospectively analysed to identify the most relevant metrics within the time series of vital signs for early detection of Idiopathic Pulmonary Fibrosis exacerbations and to assess the feasibility of early detection of Idiopathic Pulmonary Fibrosis exacerbations using a score that could trigger an alert prior to the date the patient reports clinical signs or the date the pulmonologist is consulted for exacerbation of Idiopathic Pulmonary Fibrosis
Procedure
Inclusion Visit 6-minute walk test and prescription of oxygen therapy
Home Installation Visit installation of oxygen therapy by Air de Bretagne and setup of the Bora Connect bracelet and Bora Box Gateway
Follow-up Visit with the Pulmonologist at 6 months M6 routine examinations satisfaction questionnaire and quality of life questionnaire
End of Study Visit with the Pulmonologist at 12 months M12 routine examinations satisfaction questionnaire and quality of life questionnaire
In case of exacerbation the follow-up will be extended by 3 months to collect post-exacerbation data
To do this they will be equipped with a Bora Band connected wristband that measures vital signs at home and the Bora Box Gateway that ensures connectivity and allows automatic data uploading in real time to the Bora Connect data visualization platform
The home healthcare provider Air de Bretagne will be involved in the study to support each patient in the use of the connected wristband
At the end of the follow-up period the collected data will be retrospectively analysed to identify the most relevant metrics within the time series of vital signs for early detection of Idiopathic Pulmonary Fibrosis exacerbations and to assess the feasibility of early detection of Idiopathic Pulmonary Fibrosis exacerbations using a score that could trigger an alert prior to the date the patient reports clinical signs or the date the pulmonologist is consulted for exacerbation of Idiopathic Pulmonary Fibrosis
Procedure
Inclusion Visit 6-minute walk test and prescription of oxygen therapy
Home Installation Visit installation of oxygen therapy by Air de Bretagne and setup of the Bora Connect bracelet and Bora Box Gateway
Follow-up Visit with the Pulmonologist at 6 months M6 routine examinations satisfaction questionnaire and quality of life questionnaire
End of Study Visit with the Pulmonologist at 12 months M12 routine examinations satisfaction questionnaire and quality of life questionnaire
In case of exacerbation the follow-up will be extended by 3 months to collect post-exacerbation data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None